ISO 9001 Standard - ISO 9001 Standards

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Audit Of Electronic Documents In ISO 9001 Standards

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

ISO 9001 Standards – Design and Development

ISO 9001 Standards - Design and Development

Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions

- Stages of design and development

- Appropriate review, verification, and validation activities for each stage

- Responsibility and authority for design and development

The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.

NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.

Determine product requirement inputs and maintain records. The inputs must include:

- Functional and performance requirements

- Applicable statutory and regulatory requirements

- Applicable information derived from similar designs

- Requirements essential for design and development

Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.

Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:

- Meet design and development input requirements

- Provide information for purchasing, production, and service

- Contain or reference product acceptance criteria

- Define essential characteristics for safe and proper use

- Be approved before their release

Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:

- Evaluate the ability of the results to meet requirements

- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

ISO 9001 Standards - Control of Measuring and Monitoring Equipment

Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.

Where necessary to ensure valid results:

- Calibrate and/or verify the measuring equipment at specified intervals or prior to use

- Calibrate the equipment to national or international standards (or record other basis)

- Adjust or re-adjust as necessary

- Identify the measuring equipment in order to determine its calibration status

- Safeguard them from improper adjustments

- Protect them from damage and deterioration

Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.

Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).

NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

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ISO 9001 Quality Standards

In 1987, mounting concern on global quality issues led the International Organization for Standardization, or ISO, headquartered in Geneva, Switzerland, to establish a series of international quality standards. Called the ISO 9000 Series of Standards, the series is not specific to any one industry, but when used with proper industry-specific standards, helps build a strong foundation for a quality system. The idea behind ISO is to promote standardization which will facilitate the international exchange of goods and services.
Currently, ISO 9000 certification is voluntary and not required or mandated in any country. However, the European community has recently required that quality systems of many suppliers of products related to health, safety, and the environment be formally registered, by a third party, according to the ISO 9001 Standard. This action has made adoption of the ISO 9001 standards a prerequisite for doing business in Europe. Countries in Asia, Africa, and South America are more and more considering adoption of these standards as a means to increased trade among themselves and the United States. Over 20,000 companies have been registered worldwide, and at least 52 nations are implementing the standards.
In the U.S., the ISO 9000 Series of Standards was adopted in precise format as the ANSI/ASQC Q90 series of standards. The series comprises five individual, but related, international standards on quality management and quality assurance, known as ISO 9000, 9001, 9002, 9003, and 9004. For a company’s quality system to become registered in one or more of these standards involves having an accredited, independent third party conduct an audit of the company’s operations against the requirements of the ISO 9001 standards. Upon successful completion of this audit, the company will receive a registration certificate that identifies its quality system as being in compliance with ISO 9001 standards.

ISO 9001 – Benefits and Problems

ISO 9000 has received much publicity. Some managers see it as a prerequisite for conducting business. For others, it substitutes for the difficulties and vagaries of Total Quality Management (TQM). Some see only a needless bureaucratic boondoggle. Depending on the situation, any of these views might be correct.
Sensibly applied, ISO 9000 is a qualifier for international markets or specific domestic customers. Certification can be a valuable marketing tool. The standards are a sound blueprint for a quality system. They can lead the way to the more difficult and sophisticated approaches of Total Quality Management. ISO 9000 can improve a company’s cost structure by 5%-20%.
Approached unwisely, ISO 9000 can be costly and unproductive. It may create a quality bureaucracy which adds to the cost structure and slows product development. It can focus people on paperwork instead of customers. It can divert management concentration and energy from more vital issues.

Revising the ISO 9001 Quality Manual

Revising the ISO 9000 quality procedures and the ISO 9000 quality manual should be a normal part of the ever-improving ISO 9000 quality system. These revisions can reach from small corrections to a total makeover of the entire ISO 9000 quality system. If you find your company’s ISO 9000 system to be bureaucratic and cumbersome, if you find your employees completely negative about ISO 9000, and if you end up extensively preparing for each audit, then your ISO 9000 system has plenty of opportunities for improvement and you should consider a complete makeover.
Problems related to ISO 9000It is not uncommon to find employees with negative opinions on ISO 9001. Most of them complain about excessive bureaucracy, much paperwork and extra work before audits. At the same time, they feel that there are no benefits to ISO 9001.
These problems are not the fault of ISO 9001 – these problems result from the way the ISO 9001 quality management system was implemented!

ISO 9000 Documentation

ISO 9001 requires several different documents: a quality manual, quality procedures, a quality policy and quality objectives; in addition, ISO 9001 requires work instructions that provide detailed guidelines to employees on how to perform their work. However, the ISO 9001 standard is very clear that work instructions need only be created where they add value (for example, a trained painter will not find value in instructions on how to paint; on the other hand, brief instructions (possibly in form of pictures), displayed right on a machine, explaining how to replace a filter could be a great time saver). Forms, which must be kept on file after they are filled in, are also part of any ISO 9001 quality management system. Some of the most typical forms are the Corrective Action Report Form, the Employee Review Form, and the Customer Survey. It is important to note that ISO 9001 does not directly require these forms; however, ISO 9001 calls for recording certain information and a well-designed form not only requires the information but it also walks the user through the process.